Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 10, 2025 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: reference character “351b” has been used to designate both the first electrode and the second electrode (see e.g. para. 0078); likewise, “the second electrode” is designated by two different reference characters “351b” and “352b” (see e.g. para. 0078), and the “the third electrode” by “351c” and “352c” (see e.g. para. 0078).
Appropriate correction is required.
Claim Objections
Claim 5 is objected to because of the following informalities: in line 6, “first, two, three, and four” should be “first, second, third, and fourth”. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 9-13, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over US 20080183251 A1 (Azar) in view of WO 2021167109 A1 (Yamazaki).
Regarding Claim 1, Azar teaches a skin care device [40] comprising:
a body [40A] including a first terminal (see Fig. 4; see also para. 0134);
and a head portion [76] connected to the body and detachable from the body, wherein the head portion includes:
a housing [78] including an accommodation space [80A-D] therein (see Fig. 4);
a substrate [100A] disposed in the housing (see Figs. 4-5);
an electrode portion [78A-D] disposed in the housing and disposed on the substrate (see Figs. 4-5);
and a second terminal [62] located below the substrate and electrically connected to the first terminal of the body (see Fig. 2; see also para. 0134);
wherein the electrode portion includes:
a first electrode [78A];
a second electrode [78B];
a third electrode [78C];
and a fourth electrode [78D] wherein the first, second, third and fourth electrodes operate in a first RF mode, and wherein the first RF mode is applied to two of the first, second, third, and fourth electrodes at different frequencies alternately at a predetermined period (see para. 0057-0058), so that high- frequency thermal energy is evenly transmitted from an upper dermal layer to a lower dermal layer (see para. 0093, “systems disclosed herein enable . . . uniform heating of all skin layers”).
Although Azar teaches that the device may be designed to accept any number of different types of RF electrode assemblies (see para. 0335) and that the geometrical arrangement of the RF electrodes may be varied (see para. 0189), it does not explicitly disclose a design with four electrodes arranged concentrically as claimed.
Yamazaki teaches a skin care device comprising:
a first electrode [11] disposed at a center of a head portion (see Fig. 2A);
a second electrode [12] surrounding a periphery of the first electrode and disposed alternately at equal intervals (see Fig. 2A);
a third electrode [13] surrounding a periphery of the second electrode and disposed alternately at equal intervals (see Fig. 2A);
and a fourth electrode [14] surrounding a periphery of the third electrode and disposed alternately at equal intervals (see Fig. 2A).
It would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Azar in view of Yamazaki such that the four electrodes are arranged concentrically as claimed. Doing so would improve control of the RF energy in tissue below the skin surface to aid in more uniform thermal distribution between layers.
Regarding Claim 9, Azar teaches a negative current is applied to one of the two third and fourth electrodes, the two first and fourth electrodes, or the two first and second electrodes, and a positive current is applied to an other electrode (see e.g., para. 0105, “the RF electrodes may be arranged in pairs of bipolar arrangement”). Although Azar fails to explicitly disclose applying the current of a fifth frequency to each of the third and fourth electrodes in a step 3, each of the first and fourth electrodes in a step 4, and each of the first and second electrodes in a step 5, Azar discloses an RF mode of several separately executed steps that alternate current of a particular frequency between electrodes, wherein the current is not applied to (at least) two electrodes in each step and each step uses a different combination of electrodes (see e.g. Figs. 8A-C; see also para. 0044, “the device also includes a multiplexing switching unit connected to the plurality of RF energy generating units, the plurality of electrodes and the at least one controller unit for controllably applying RF energy from any combination of RF energy generating units selected from the plurality of RF energy generating units to any electrode or electrode combination selected from the plurality of electrodes”).
It would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of Azar to apply the current of a fifth frequency to each of the third and fourth electrodes in a step 3, each of the first and fourth electrodes in a step 4, and each of the first and second electrodes in a step 5. Doing such sequencing is one of a finite number of possibilities that a person having ordinary skill in the art could select from in order to alternate treatment between four electrodes in pairs as taught in Azar to improve treatment outcomes with a reasonable expectation of success (see e.g. Figs. 8A-C and para. 0181, “any type of electrode pair switching sequence may be programmed into the devices of the present application. For example, in accordance with one embodiment of the devices and systems of the present application, the controller unit 8 may be programmed or configured for repeating a specific pre-set or pre-programmed sequence of electrode pair activations“).
Azar further fails to disclose that the first, second, third, and fourth electrodes can operate in a first EMS mode instead of the first RF mode. However, Yamazaki teaches that similar devices can operate in an EMS mode instead of an RF mode by selecting the appropriate frequencies for muscle stimulation (e.g., 1 Hz to 100 kHz) (see p. 3, para. 7-8, “parameters such as the frequency to be generated can be appropriately set according to the purpose of applying the electric current (muscle stimulation, heat, promotion of penetration of the lotion into the inside, etc.).). It would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Azar in view of Yamazaki so as to include an EMS mode as claimed by adjusting the electrode frequencies accordingly. Doing so would help achieve a muscle stimulation effect, as evidenced by Yamazaki.
Regarding Claim 10, Azar teaches that no current is supplied to the electrodes for a certain period of time between steps (see para. 0173, “when switching pairs of electrodes or groups of electrodes, the controller unit 8 (or any other type of controller unit used in implementing the device) of the device may switch off the RF current for a short period of time”). However, Azar fails disclose that in a first EMS mode, one of stimulation level 1, stimulation level 2, and stimulation level 3, which are set in an order from shortest to longest, is selected and executed so that a stimulation time in each of the step 3, the step 4, and the step 5 is different.
Yamazaki teaches that stimulation time may be varied between user selected modes (see page 5, para. 5, “the operation mode may be directly specified by the user via the switch 90, or is determined from the . . . application time, and other parameters related to application specified by the user via the switch 90”). As such, in the combination of Azar and Yamazaki discussed above, it would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to further provide the device with several stimulation levels to select from which vary in their stimulation time. Doing so would provide more options to the user to optimize treatment.
Regarding Claim 11, Azar teaches repeatedly executing steps for a certain period of time (see Azar para. 0054, “the method also includes repeating the first step of applying and the second step of applying a plurality of times”). In the combination of Azar and Yamazaki as discussed above, it would have been obvious for a person having ordinary skill in the art to also repeatedly execute the steps in the EMS mode as claimed. Doing so would help maintain uniform treatment effects while also avoiding overheating.
Regarding Claim 12, Azar fails to disclose the first, second, third, and fourth electrodes operate in a RF+EMS mode instead of the first RF mode, wherein the RF+EMS mode is divided into step 6, step 7, and step 8 which are separately executed in a manner of which when the second RF mode is operated in two of the first, second, third, and fourth electrodes, and the second EMS mode is operated in other two electrodes. However, Yamazaki discloses operating the device in a RF+EMS divided into three steps (T0, T1, T2) which are separately executed in a manner of which when the second RF mode is operated in two of the electrodes, the second EMS mode is operated in the other two electrodes (see p. 6, para. 8-9 and p. 7, para. 1-2). It would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Azar in view of Yamazaki to include a RF+EMS mode as claimed. Doing so would serve to also achieve a muscle stimulation effect, as evidenced by Yamazaki.
Regarding Claim 13, in the combination of Azar and Yamazaki discussed above, it would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to sequence the electrodes such that the first and second electrodes are executed in the second RF mode and the third and fourth electrodes are executed in the second EMS mode in the step 6, the second and third electrodes are executed in the second RF mode and the first and fourth electrodes are executed in the second EMS mode in the step 7, and the third and fourth electrodes are executed in the second RF mode and the first and second electrodes are executed in the second EMS mode in the step 8. Azar and Yamazaki teach that electrode pairs in each step can be switched in sequence to optimize treatment and avoid overheating, and the specific sequence as claimed is one of a finite number of possibilities when sequencing two electrode pairs (RF+EMS) using four total electrodes.
Regarding Claim 18, Azar teaches repeatedly executing steps for a certain period of time (see Azar para. 0054, “the method also includes repeating the first step of applying and the second step of applying a plurality of times”). In the combination of Azar and Yamazaki as discussed above, it would have been obvious for a person having ordinary skill in the art to also repeatedly execute the steps in the RF+EMS mode as claimed. Doing so would maintain uniform treatment effects while also avoiding overheating.
Claim(s) 2-3 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over US 20080183251 A1 (Azar) in view of WO 2021167109 A1 (Yamazaki) and further in view of US 20100087899 A1 (Erez).
Regarding Claims 2-3, Azar and Yamazaki do not explicitly teach the first RF mode sets frequencies to be used for the first, second, third, and fourth electrodes to four frequencies in a range of 1 MHz to 3 MHz, and wherein the four frequencies are set to a first frequency, a second frequency, a third frequency, and a fourth frequency in an order from longest to shortest frequency (2.2 MHz, 1.8 Mhz, 1.4 Mhz, and 1.0 Mhz, respectively). Instead, Azar teaches frequency ranges of, for example, 0.35 Mhz -1.5Mhz and 4 Mhz -15 Mhz (see para. 0059). However, Azar also suggests that other frequency values can be useful depending on the tissue being targeted (see e.g., para. 0275), and that using a higher number of frequencies or frequency ranges than the explicitly disclosed two is possible (see para. 0280, “it may also be possible to use more than two RF frequencies”).
Erez teaches setting three different frequencies for a skin treatment that all fall near or within the claimed range and values (specifically, 2.4 Mhz, 1.5 Mhz, and 0.8 Mhz) (see para. 0029). Erez further teaches the chosen frequencies can be modified as desired to treat different layers (depths) of tissue (see para. 0009 and 0027). Both Azar and Erez teach that the frequencies of the RF electrodes need to be optimized according to the depth or type of tissue layer being treated and based on the desired resulting thermal profile. The frequency of the current of the RF electrodes is therefore disclosed to be a result effective variable in that changing the frequency changes how efficiently the energy is absorbed by the targeted tissue type, which affects the uniformity of the thermal distribution across it and other layers surrounding it. It would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Azar by choosing to set a first frequency to 2.2 MHz, a second frequency to 1.8 MHz, a third frequency to 1.4 MHz, and a fourth frequency to 1.0 MHz as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding Claim 14, Azar and Yamazaki do not explicitly teach the second RF mode sets frequencies to be used for the first, second, third, and fourth electrodes to four frequencies in a range of 1 MHz to 3 MHz (high frequency), wherein the four frequencies are set to a first frequency, a second frequency, a third frequency, and a fourth frequency in an order from longest to shortest frequency, and wherein the second EMS mode sets frequencies to be used for the first, second, third, and fourth electrodes to five frequencies in a low frequency range. However, It would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to use the claimed frequencies for the RF mode in view of Erez as discussed in Claims 2-3 above. It would have likewise been obvious to set the frequencies in the EMS mode to five frequencies in a low frequency range in view of Yamazaki, which teaches using low frequencies for EMS (e.g., 1 Hz to 100 kHz) (see p. 3, para. 7-8)
Claim(s) 4-8 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over US 20080183251 A1 (Azar) in view of WO 2021167109 A1 (Yamazaki) and US 20100087899 A1 (Erez) and further in view of US 20200237424 A1 (Hunziker).
Regarding Claims 4 and 15, Azar and Yamazaki each disclose negative and positive currents applied to electrode pairs (see e.g. Azar para. 0162; see also Yamazaki p. 5, para. 6). Yamazaki further discloses an acceleration period [T0] for rapid thermal transfer to a skin before operating the first RF mode (see Fig. 7). However, Azar, Yamazaki, and Erez fail to explicitly disclose an acceleration levels wherein one of acceleration level 1, acceleration level 2, and acceleration level 3, which are set in an order from longest to shortest time, is selected and operated in the acceleration mode, wherein the third and fourth electrodes are supplied with a current of the first frequency at a duty of 100%.
Hunziker teaches an acceleration mode (i.e., an initial warm up period) for rapid thermal transfer to a skin before operating a first RF mode (see para. 0280, “the target tissue can be raised to the therapeutic temperature range (e.g., 42-47° C.) during an initial heating or build phase in which the RF power (or duty cycle) is increased, after which the RF power (or its duty cycle) can be reduced to maintain the target tissue in the desired therapeutic temperature range (e.g., at its plateau of about 45° C.).”) wherein applicators are supplied with a current of a first frequency at a total duty cycle of 100%, split evenly between the three applicators (see Fig. 5A) (see also para. 0137, “generators . . . can be operated at 100% duty”). While Hunziker does not explicitly teach three acceleration levels in one embodiment with different corresponding time periods, Hunziker does teach three embodiments with varying predetermined periods of time for the warm-up periods (e.g., less than 180, 120, and 60 seconds) (see para. 0054).
It would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Azar in view of Yamazaki and Erez and further in view of the combined embodiments of Hunziker so as to include an acceleration mode with three different acceleration levels, wherein the third and fourth electrodes are supplied with a current of a first frequency at a duty of 100%. Doing so would allow the user to select from appropriate acceleration time periods, quickly raising the tissue temperature to the desired therapeutic temperature range for more efficient treatment, as recognized by Hunzkier (see para. 0280).
Regarding Claim 5, Azar teaches the RF mode is automatically stopped after the certain period of time lapses (see para. 0052-0054), and wherein the first RF mode is divided into step 1 and step 2 which are separately executed in a manner of which when two of the first, second, third, and fourth electrodes are alternately applied with two of the frequency currents (see para. 0057-0058) no current is supplied to the other two electrodes (see para. 0163). It would have been obvious to use the first, second, third, and fourth frequencies in view of Erez and as a matter of routine optimization as discussed in Claims 2-3, and to execute the RF mode for a certain period of time from when the acceleration mode is completed in view of Azar as discussed in Claim 4.
Regarding Claim 6, Azar teaches the first RF mode is configured to apply negative current to one of the two first and second electrodes or the two third and fourth electrodes, and a positive current is applied to an other electrode (see e.g. para. 0162), and wherein the step 1 and the step 2 are alternately executed with a gap of a second set time during which no current is supplied to each of the first, second, third, and fourth electrodes (see para. 0173, “when switching pairs of electrodes or groups of electrodes, the controller unit 8 (or any other type of controller unit used in implementing the device) of the device may switch off the RF current for a short period of time”).
Azar fails to explicitly disclose applying the currents of the second frequency and the fourth frequency alternately to each of the first and second electrodes several times to several tens of times at a period of less than 1 second during a first set time in the step 1 and applying the currents of the first frequency and the third frequency alternately to the third and fourth electrodes several times to several tens of times at the period of less than 1 second during the first set time in the step 2.
Erez teaches alternating RF energy frequencies in a single treatment cycle, wherein the currents are applied several times at a period of less than 1 second (e.g., 350 milliseconds) (see para. 0006). In the combination of Azar, Yamazaki, Erez, and Hunziker as previously discussed, it would have been obvious to further include that the currents are applied several times at a period of less than 1 second for each step in view of Erez. Controlling the timing of the RF pulses is an additional way to further control the resulting thermal energy distribution, and the claimed range of several times at a period of less than 1 second falls within what is disclosed in the art, as evidenced by Erez.
Regarding Claim 7, Azar teaches modifying the RF current application duration in the RF modes (such as in the claimed first set time) to help optimize current flow (see para. 0188 “Those skilled in the art will appreciate that many different variations of RF current application regimes and/or modes and/or sequences may be used in implementing the devices and systems of the present application by varying or modifying one or more parameters of the applied RF currents, including but not limited to . . . RF current frequency [and] RF current application duration”). Azar also teaches that cool-off periods (such as in the claimed second set time) can prevent overheating (see e.g. para. 0163, “allowing these electrodes to cool . . . avoids or reduces overheating of the electrodes”). It would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of Azar so that the first set time becomes longer from the acceleration level 1 to the acceleration level 3. Lowering the duration of the first set time, which is a treatment period, in the lower acceleration levels relative to the higher ones would help achieve more similar results between acceleration levels since the lower acceleration levels have the longer warm-up periods (and therefore foreseeably need less time to efficiently treat tissue). It would have likewise been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of Azar so that the second set time becomes relatively shorter from the acceleration level 1 to the acceleration level 3. Increasing the second set time, which is a cool-off period, in the lower acceleration levels relative to the higher ones would help achieve similar results between acceleration levels since the lower acceleration levels have the longer warm-up periods (and therefore foreseeably need longer time to cool-off).
Regarding Claim 8, Azar (in view of Yamazaki, Erez, and Hunziker as discussed above) teaches the first RF mode is repeatedly executed for the certain period of time in an order of the step 1-> the step 2-> the step 1-> the step 2 after the acceleration mode (see Azar para. 0054, “the method also includes repeating the first step of applying and the second step of applying a plurality of times”).
Regarding Claim 16, Azar teaches the first RF mode is configured to apply negative current to one electrode of a pair and a positive current is applied to an other electrode (see e.g. para. 0162), and wherein steps are alternately executed with a gap of a second set time during which no current is supplied to each of the first, second, third, and fourth electrodes (see para. 0173, “when switching pairs of electrodes or groups of electrodes, the controller unit 8 (or any other type of controller unit used in implementing the device) of the device may switch off the RF current for a short period of time”).
Azar fails to explicitly disclose applying the currents of the first frequency and the second frequency alternately to each of the first and second electrodes in a step 6, applying the currents of the second frequency and the third frequency alternately to each of the second and third electrodes in a step 7, and applying the currents of the first frequency and the third frequency alternately to the third and fourth electrodes in a step 8, each at several times to several tens of times at the period of less than 1 second during the first set time.
Erez teaches alternating RF energy frequencies in a single treatment cycle, wherein the currents are applied several times at a period of less than 1 second (e.g., 350 milliseconds) (see para. 0006). In the combination of Azar, Yamazaki, Erez, and Hunziker as previously discussed, it would have been obvious to further include that the currents are applied alternately several times at a period of less than 1 second for each step in view of Erez. Controlling the timing of the RF pulses is an additional way to further control the resulting thermal energy distribution, and the claimed range of several times at a period of less than 1 second falls within what is disclosed in the art, as evidenced by Erez.
Azar further teaches modifying the current application duration in the RF modes (such as in the claimed first set time) to help optimize current flow (see para. 0188 “Those skilled in the art will appreciate that many different variations of RF current application regimes and/or modes and/or sequences may be used in implementing the devices and systems of the present application by varying or modifying one or more parameters of the applied RF currents, including but not limited to . . . RF current frequency [and] RF current application duration”). Azar also teaches that cool-off periods (such as in the claimed second set time) can prevent overheating (see e.g. para. 0163, “allowing these electrodes to cool . . . avoids or reduces overheating of the electrodes”). It would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of Azar so that the second set time becomes longer from the acceleration level 1 to the acceleration level 3. Lowering the duration of the first set time, which is a treatment period, in the lower acceleration levels relative to the higher ones would help achieve more similar results between acceleration levels since the lower acceleration levels have the longer warm-up periods (and therefore foreseeably need less time to efficiently treat tissue). It would have likewise been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of Azar so that the second set time becomes relatively shorter from the acceleration level 1 to the acceleration level 3. Increasing the second set time, which is a cool-off period, in the lower acceleration levels relative to the higher ones would help achieve similar results between acceleration levels since the lower acceleration levels have the longer warm-up periods (and therefore foreseeably need longer time to cool-off).
Although Azar fails to explicitly disclose applying the current of a fifth frequency to each of the third and fourth electrodes in a step 6, each of the first and fourth electrodes in a step 7, and each of the first and second electrodes in a step 8, Azar discloses several separately executed steps that alternate current of a particular frequency between electrodes, wherein the current is not applied to (at least) two electrodes in each step and each step uses a different combination of electrodes (see e.g. Figs. 8A-C; see also para. 0044, “the device also includes a multiplexing switching unit connected to the plurality of RF energy generating units, the plurality of electrodes and the at least one controller unit for controllably applying RF energy from any combination of RF energy generating units selected from the plurality of RF energy generating units to any electrode or electrode combination selected from the plurality of electrodes”).
It would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of Azar to apply the current of a fifth frequency to each of the third and fourth electrodes in a step 6, each of the first and fourth electrodes in a step 4, and each of the first and second electrodes in a step 8. Doing so is one of a finite number of possibilities that a person having ordinary skill in the art could select from in order to alternate treatment between four electrodes in pairs as taught in Azar to improve treatment outcomes with a reasonable expectation of success (see e.g. Figs. 8A-C and para. 0181, “any type of electrode pair switching sequence may be programmed into the devices of the present application. For example, in accordance with one embodiment of the devices and systems of the present application, the controller unit 8 may be programmed or configured for repeating a specific pre-set or pre-programmed sequence of electrode pair activations“).
Regarding Claim 17, Azar teaches that no current is supplied to the electrodes for a certain period of time between steps (see para. 0173, “when switching pairs of electrodes or groups of electrodes, the controller unit 8 (or any other type of controller unit used in implementing the device) of the device may switch off the RF current for a short period of time”). However, Azar fails disclose that in a second EMS mode, one of stimulation level 1, stimulation level 2, and stimulation level 3, which are set in an order from shortest to longest, is selected and executed so that a stimulation time in each of the step 3, the step 4, and the step 5 is different. Yamazaki teaches that stimulation time may be varied between user selected modes (see page 5, para. 5, “the operation mode may be directly specified by the user via the switch 90, or is determined from the . . . application time, and other parameters related to application specified by the user via the switch 90”). In the combination of Azar and Yamazaki discussed above, it would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to further provide the device with several stimulation levels to select from which vary in their stimulation time. Doing so would provide more options to the user to optimize treatment.
Conclusion
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/C.S./Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
